Kornimate/medical-research-clean huggingface dataset:
analgesia in patients undergoing transfemoral transcatheter aortic valve implantation (tf-tavi)

Conditions: Aortic Valve Stenosis

Summary: ilioinguinal and iliohypogastric (ilih) nerve blocks are frequently performed for analgesia in inguinal surgery. the investigators hypothesized that preoperative ultrasound-guided ilioinguinal and iliohypogastric (ilih) nerve blocks will produce better intraoperative analgesia and less analgesic requirement postoperatively in comparison to commonly used preoperative local infiltration anaesthesia for patients undergoing transfemoral transcatheter aortic valve implantation (tf-tavi).

it is a prospective, randomized trial. the patients will be randomized to one of the 2 groups: group 1 - nerve block. ultrasound-guided ilih nerve block will be performed by attending anaesthesiologist. group 2 - local infiltration. local anaesthetic infiltration of the operative area will be performed by operator. during surgery patients will receive low-dose propofol infusion in order to achieve conscious sedation level, when indicated. an extra dose of local anaesthetic drug for infiltration of the surgical field or intravenous fentanyl or/and intravenous paracetamol will be given as rescue analgesics in patients reporting pain sensation. the patients will be observed for 24 hours. the pain at rest will be assessed using numeric rating scale (nrs 0 -10; 0 = no pain: 10 = max pain imaginable). on the first postoperative day intravenous analgesics will be given on demand (paracetamol 1 g iv (if nrs \ or = 5)).

Eligibility criteria:
inclusion criteria: * patients with aortic valve stenosis referred for tf-tavi * using a minimalist approach of local anesthesia or nerve block with conscious sedation exclusion criteria: * patient's refusal to participate * allergy to local anaesthetic * tf-tavi requiring general anesthesia or surgical cut-down * patients with major cognitive impairment and inability to assess their pain level in numerical rating scale (nrs).

Keywords: ilioinguinal iliohypogastric nerve block local anaesthesia infiltration ultrasound-guided pain control
stop pain: septal closure of pfo - does it prevent migraine?

Conditions: Migraine

Summary: the primary objective of this study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.


Eligibility criteria:
inclusion criteria: * migraine history of at least 1 year. * migraine patients experiencing at least 2 migraine attacks per month. * migraine patients experiencing at least 1 migraine attack with aura per month. * failure of or intolerance to at least 2 classes of prophylactic migraine medication evaluated in adequate, approved medication trials. at least one of the classes shall come from beta-blockers, anticonvulsants, calcium channel blockers and tricyclic antidepressants. * aged 18 - 50 years and of legal age in the host country. * the patient or legal guardian has signed a study specific informed consent form agreeing to data collection and follow-up requirements. * the patient agrees to abstain from starting prophylactic migraine medication or agrees to maintain existing prophylactic migraine medication without changing dose or drug from entering the baseline period throughout the duration of the study until final assessments. * documented right to left shunt that is suitable for device closure. exclusion criteria: * taking migraine preventative medication for conditions other than migraine. * history of 15 or more headache days per month. * 8 or more non-migraine headache days per month. * overuse of acute headache medication (use on 10 or more days per month). * patient has severe central nervous system disease such as seizure disorder, inflammatory disease of the central nervous system, or a previous stroke. * previous surgical or device closure of a pfo or asd. * artificial heart valve. * pacemaker or icd implanted within past 3 months. * anatomic variant that could affect successful deployment such as coronary sinus, pulmonary veins, chiari network. * uncontrolled bacteremias or dental or surgical procedure within past 30 days or planned within study period. * allergy to contrast media, and/or to any component of the device to be used. * contraindicated for any medication used during or after the procedure. * history of atrial fibrillation or atrial flutter (chronic or paroxysmal). * patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study. * patient is undergoing dialysis for renal failure. * patient has nyha class 3 or 4 cardiac failure. * patient is pregnant, or intends to become pregnant during the trial period. * patient requires anticoagulation therapy for a concomitant condition.
palbociclib plus tamoxifen for the treatment of hormone receptor-positive, her2-negative advanced breast cancer women - asian study

Conditions: Breast Neoplasms

Summary: this study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (hr)-positive, her2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).


Eligibility criteria:
inclusion criteria: * women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent * documented diagnosis of hr+/her2- breast cancer * any menopausal status * previously untreated with any endocrine therapy for their hr+/her2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. if patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor. * measurable disease or non-measurable disease as defined by recist ver.1.1 * eastern cooperative oncology group (ecog) ps 0-1 * adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures exclusion criteria: * prior treatment with any cdk inhibitor, tamoxifen, everolimus, or agent that inhibits the pi3k-mtor pathway * patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic cns metastases * use of strong or moderate cyp3a4 and/or cyp2d6 inhibitors or inducers * major surgery or any anti-cancer therapy within 2 weeks of randomization * prior stem cell or bone marrow transplantation

Keywords: breast cancer palbociclib (pd-0332991) tamoxifen goserelin any menopausal status hormone receptor positive her2 negative locally advanced metastatic
methemoglobinemia after liposuction - diagnostic by pulse oximetry and blood gas analysis.

Conditions: Methemoglobinemia

Summary: tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic surgical procedures such as liposuction. the subcutaneous adipose tissue is infiltrated with large volumes of a solution which also contain local anesthetics. however local anesthetics, can also lead to a marked production of methemoglobin. new generation pulse oximeters are able to measure spmethb non-invasivly. the aim of this study is: 1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at increased risk for methemoglobinemia. 2. to illustrate methb concentrations over a course of 24 hours after a liposuction employing tumescent anesthesia has been carried out.


Eligibility criteria:
inclusion criteria: * planned liposuction in tumescent local anesthesia exclusion criteria: * hematologic disorders

Keywords: pulse oximetry tumescent anesthesia
chemical analysis of limb microfluidics

Conditions: Limb Ischemia; Compartment Syndrome of Leg

Summary: compartment syndrome (cs) is a condition where an increase in pressure in an anatomical compartment (e.g. the lower leg) affects the blood supply of the tissues, leading to tissue damage. the condition is difficult to diagnose, and more difficult to determine when and how to manage it. treatment aims to reduce the pressure in the compartment by whatever means possible. surgical management by of cs is highly invasive and has associated risks including infection, damage to local structures (i.e. nerves), and possibly the inability to close the wound leading to the need for further reconstructive procedures. the clinical challenge in suspected cs is knowing if and when to intervene. some cases of mild cs may resolve without an operation, and therefore intervening too soon causes unnecessary harm to the patient. however, waiting too long to operate with high compartmental pressures may lead to irreversible damage to the tissues, resulting in either a useless limb or necrotic tissue needing amputation. current strategies for determining limb health include interrogation of symptoms, signs on examination, and serial measurements of compartmental pressures, but no absolute measurement of tissue health. as such, there is an element of clinical judgment in management and no evidence base with which to develop clear treatment guidelines. there is a need for a minimally invasive method of continuously monitoring tissue health to improve the understanding of cs and its management before significant improvement in patient outcomes can be delivered. it is proposed the application of leg "microfluidics" - analysis of samples of leg fluid - in a series of predictable clinical scenarios which simulate the threatened and unsalvageable limb. this is with an ultimate aim of developing a method of limb fluid sampling that can predict if cs is present and requires intervention.


Eligibility criteria:
inclusion criteria: adult patients (aged greater than or equal to 18 years) who are either: i. undergoing an intervention where there is a controlled reduction in blood flow to the limb that is reversible (e.g. using a tourniquet or clamp) or irreversible (e.g. during limb amputation). ii. at risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team. exclusion criteria: age \<18 years old unable to provide informed consent

Keywords: microfluidics compartment syndrome limb ischaemia
fast track hip fracture - an optimized pathway for hip fracture patients

Conditions: Hip Fractures

Summary: the study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at akershus university hospital two years before and two years after this change in standard care.

the norwegian hip fracture register prospectively collects data on all hip fracture patients including, among others, time to surgery, type of fracture, type of surgery and american society of anesthesiologists (asa) score. the register also collects quality of life data 4 and 12 months after surgery. using the unique norwegian personal identification number the data from the norwegian hip fracture register will be connected with data from the electronic patient record at akershus university hospital (ahus). fast track surgery for hip fracture patients was introduced at the end of 2013. mortality and quality of life data will be compared for all hip fracture patients operated at ahus two years before and two years after this change in standard care. the combined data from the register and the electronic patient records will be used for regression analysis.

Eligibility criteria:
inclusion criteria: * operated at akershus university hospital for a hip fracture (neck of femur, trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015 * 18 years or older exclusion criteria: * stress fracture

Keywords: fast track
effects of microcrystalline titanium dioxide with covalently linked monovalent silver ions on complications after total hysterectomy

Conditions: Infection; Bleeding; Complication, Postoperative

Summary: total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. the postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. the most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. the introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. in this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications. the cationic silver ions (ag +) stabilized by covalent link with titanium dioxide (tio2), the tiab, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. thanks to these properties, tiab is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. in addition to microbicidal and disruptive biofilm activity, tiab has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling. different clinical trials have reported a cicatrizing and re-epithelializing action of tiab administered vaginally in the context of cervical conization for pathology related to hpv. without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients. on the basis of the available evidence, we conduct a randomized controlled clinical trial to determine if tiab treatment in the formulation of vaginal capsules tiagin (tiab (microcrystalline titanium dioxide with covalently linked monovalent silver ions), sodium hyaluronate, aloe barbadensis extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.


Eligibility criteria:
inclusion criteria: * women underwent laparoscopic total hysterectomy for benign gynecological pathology exclusion criteria: * women underwent non-laparoscopic total hysterectomy * women underwent laparoscopic total hysterectomy for malignant pathology * patients with diabetes mellitus in insulin therapy * smoking patients * patients suffering from chronic rheumatic diseases or chronic diseases not in adequate control.
a retrospective multicenter study to determine 5-year clinical outcomes in subjects previously enrolled in the ctot-01 study

Conditions: Kidney Disease; Kidney Failure; End Stage Renal Disease

Summary: this study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (ctot-01, nct00308802) in first six-month post-transplant is predictive of 5-year outcomes. each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.


Eligibility criteria:
inclusion criteria: * participants previously enrolled in the ctot-01 study. * participants who are at least 5 years post-transplant (+/- 6 months), no later than march 31, 2014. exclusion criteria: * withdrawal of consent to continue in the ctot-01 study.

Keywords: kidney transplant rejection
effects of a health-at-every-size approach on weight management in premenopausal overweight women

Conditions: Overweight

Summary: the purpose of this study is to measure the effects of a health-at-every-size (haes) approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts.

weight management is a critical issue in developed countries where the prevalence of obesity is increasing. poor long-term success observed with current weight-control strategies stresses the relevance to explore new weight management approaches. one of these approaches, referred to as health-at-every-size (haes), is a new weight paradigm that focuses on a healthy lifestyle by promoting overall health benefits of behavioral changes related to dietary habits and physical activity and emphasizes self-acceptance and well-being, independently of body weight status. studies on the effects of a haes approach have shown significant improvements in metabolic and psychological variables. to our knowledge, no study has yet reported the short and long-term impacts of a haes approach on a cluster of variables (psychological, morphological, metabolic, and nutritional) in women. the aim of this study is to measure the effects of a haes approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts. in this parallel controlled trial, women will be randomized to one of the 3 treatment conditions: haes group, social support group (ss), or control group. measurements will be taken in the short term as well as in the long term (up to 1 year post-intervention).

Eligibility criteria:
inclusion criteria: * healthy premenopausal women from quebec city metropolitan area * age: between 30 to 50 years old * stable body weight (+/- 2 kg) for at least 2 months before the beginning of the study * overweight or obesity: body mass index \[bmi\] between 25 and 35 kg/m2 * preoccupation about weight and eating: showing overconcern with shape and weight, exhibiting restriction over food choices for at least 2 years, and having been unsuccessful in previous attempts to lose weight (for at least the past 2 years) * current weight corresponding to maximum weight reached during adult lifetime exclusion criteria: * women currently dieting to lose weight * taking oral contraceptives or postmenopausal status * pregnant or lactating women * under treatment for coronary heart disease, diabetes, dyslipidemia, hypertension, depression or endocrine disorders (with the exception of stable thyroid disease) * women presenting metabolic or important psychological disorders (drug or alcohol abuse, bulimia, ...) * women who had already take part to the health-at-every-size (haes) approach

Keywords: weight management new weight paradigm overweight women eating behaviors appetite ratings blood lipids
cannabidiol (cbd) for treatment of aromatase inhibitor-associated arthralgias

Conditions: Arthralgia; Breast Cancer

Summary: study of cannabidol to examine the safety and efficacy of 15 weeks of cbd in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (aimss). investigators are looking to see if patients with joint pain see improvement with the use of cbd.


Eligibility criteria:
inclusion criteria: * postmenopausal according to standard clinical criteria or receiving concomitant lhrh agonist therapy. * taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment. * planning to take the same ai therapy for at least 15 weeks. * new or worsening joint pain and/or myalgias since starting the ai therapy. * completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment. * the complete list of inclusion criteria is provided in the protocol. exclusion criteria: * metastatic breast cancer. * planned surgery during the 15-week study period. * clinically significant laboratory abnormalities. * use of cannabidiol, thc, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment. * history of or currently has suicidal ideation or attempted suicide. * history of seizure other than febrile seizures in childhood. * the complete list of exclusion criteria is provided in the protocol.

Keywords: cannabidiol
sublingual misoprostol versus standard surgical care for the treatment of incomplete abortion

Conditions: Incomplete Abortion

Summary: in this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. this study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. women could significantly benefit from a non-invasive treatment option for incomplete abortion. while safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. especially in developing countries, infection, hemorrhage and uterine damage are still too common. medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.


Eligibility criteria:
inclusion criteria: * uterine size no larger than 12 weeks lmp at time of presentation for care. * past or present history of vaginal bleeding during pregnancy. * open cervical os. * if ultrasound used evidence of incomplete abortion with substantial debris in the uterus. * all women would have been advised to have surgical evacuation of the uterus if misoprostol was not available. * general good health. * willing to provide contact information for purposes of follow-up. * also in egypt: 21 years of age or over or parental permission (there is no minimum age requirement in niger, mauritania and senegal). exclusion criteria: * contraindications to study drug * signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever \> 38 degrees c , 3) uterine tenderness * hemodynamic disturbances (pulse \>110/min and systolic bp \<100) * have an iud in place; (the iud may be removed making the woman eligible) * suspected ectopic pregnancy

Keywords: misoprostol incomplete abortion pac